The Hemostatic Effectiveness of "HANBIO" Gauze During Non-emergent Gynecology Surgery.

May 28, 2025 updated by: HAN Biomedical Inc

Clinical Hemostatic Effectiveness of PET-Collagen Gauze ("HANBIO" Gauze) for Acute Wound: a Prospective, Single-arm, Open-label Evaluation Study

The objective of this study is to collect the hemostatic effectiveness and device safety data of "HANBIO" Gauze in subjects have acute wound result from gynecology surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female between 20 and 70 years of age.
  • Subject scheduled for a non-emergent, gynecological surgery.
  • Subject has an identified bleeding site/area intraoperatively.
  • Subject is willing to comply with all aspects of the study and have signed informed consent form.

Exclusion Criteria:

  • Pregnant or lactating female.
  • The wound is chronic wound that not healed within 8 weeks, e.g. ulcers.
  • The wound is caused by radiation or burns.
  • Subject is sensitive or allergic to collagen.
  • Subject is sensitive or allergic to polyester (PET).
  • Subject has medical history of coagulation disorder or disease (e.g., hemophilia, thrombocytopenia).
  • Subject receives anticoagulants or antiplatelets.
  • Subject plans to receive other hemostatic gauze/dressing/agent/medical device as primary hemostasis.
  • Subject has participated in another clinical trial within the past 30 days.
  • Subjects with any pre-operative or intra-operative findings that may preclude conduct of the study procedure or unable to evaluate the outcomes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "HANBIO" Gauze
Device: "HANBIO" Gauze (Sterilized, 1% Collagen)
After tissue resection in a standard procedure for gynecological surgery, direct application of "HANBIO" Gauze to cover the bleeding site/area which identified during dissection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Time(sec) to achieve hemostasis
Time Frame: 3 min
The mean time(seconds) required to achieve hemostasis following the application of "HANBIO" Gauze.
3 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportions of subjects achieving hemostatic success at 3 min.
Time Frame: 3 min
Subjects achieved success hemostasis within or at 3 minutes following the application of "HANBIO" Gauze.
3 min
Number/proportion of adverse and serious adverse events.
Time Frame: 3 min
Subjects had AE or SAE following the application of "HANBIO" Gauze.
3 min
Ease of use questionnaire of Product "HANBIO" Gauze (by Principal Investigator)
Time Frame: 3 min
Five questions regarding conveniency, non-adhesive property, conformability and hemostatic efficacy of "HANBIO" Gauze will be evaluated by surgeon(PI). One description, from "very satisfied", "satisfied", "neutral", "unsatisfied", "very unsatisfied", will be selected for each question.
3 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HAN Biomedical Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2024

Primary Completion (Actual)

March 31, 2025

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

November 28, 2024

First Posted (Actual)

December 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAN2018001-CT01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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